CompliantPro™ CAPA

The IBS CAPA system supports you in the continuous improvement of the quality of your products and processes, in increasing customer satisfaction and fulfilling ISO and FDA requirements.

CompliantPro™ CAPA assists with the documentation of all product and process deviations, defects and complaints and the analysis thereof. The CAPA workflow is a closed control loop and can be adapted to suit your processes. Actions planning can be used to launch immediate actions and long-term corrective actions, analyzed in terms of root-cause, prior to implementation and finally subjected to an effectiveness check. From hereon further actions can be launched, such as preventative actions, either dependently or independently of other processes.

Benefits at a glance:

Actions can be launched directly from customer complaints, deviations, risk analyses and environmental events. A reference link to the origin of the action is contained in the correction plan.

Enables specific task control thanks to automated workflows

Master data such as the product, customer or supplier serve as sources of information and enable a quick evaluation.

Individual deadline planning is integrated for each action, as are also the status and the handler.

It is possible to create several different templates (e.g. with different workflows) for the action plans

Fulfills the requirements of FDA 21 CFR Part 11, in particular those pertaining to electronic data records and second password

Full documentation with change history and Audit Trail

High degree of reliability / scalability thanks to role concept

Document Control is integrated in other CompliantPro™ components, such as CAPA, Change Management, Audits, Risk Management, etc.